A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

November 30, 2023 updated by: Topas Therapeutics GmbH

A Double-blind, Randomized, Placebo-controlled, Phase 2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamic (PD) Effects of Two Infusions of Escalating Doses of TPM502 in Adults Diagnosed With Celiac Disease

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:

  • if TPM502 is safe and well tolerated
  • if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten

Participants will:

  • undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo.
  • receive 2 infusions of TPM502 or placebo, 2 weeks apart

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD.

The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period.

Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502.

The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo).

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase >10x ULN and documented positive IgA anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines)
  • Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range (i.e., <15 U/mL) at screening
  • Serum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screening
  • Patients must have been on GFD for ≥ 6 months
  • Patients must have well-controlled CeD, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD, as per investigator's assessment
  • HLA-DQ2.5 positive

Exclusion Criteria:

  • Known or suspected refractory CeD (refractory CeD type I or II)
  • Known intolerable symptoms following previous GCs, as per investigator's assessment
  • HLA DQ8 positive
  • Any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to CeD
  • Known history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitis
  • Known wheat allergy
  • Known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: Placebo
Placebo
Experimental: TPM502
Drug: TPM502
TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, severity, causality, and outcomes of treatment-emergent adverse events
Time Frame: throughout the study, on average 43 days
throughout the study, on average 43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topas Therapeutics GmbH

Investigators

  • Principal Investigator: Knut Lundin, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCeD21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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